Effect of Autologous Peripheral Blood Stem Cell Treatment on Articular Cartilage Regeneration

March 12, 2015 updated by: Dr. Khay-Yong Saw, Kuala Lumpur Sports Medicine Centre

Articular Cartilage Regeneration With Autologous Peripheral Blood Stem Cells Versus Hyaluronic Acid: A Randomized, Controlled Trial

The purpose of this study was to compare histologic and MRI evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to compare histologic and magnetic resonance imaging (MRI) evaluation of articular cartilage regeneration in patients with chondral lesions treated by arthroscopic subchondral drilling followed by postoperative intra-articular injections of hyaluronic acid (HA) with and without peripheral blood stem cells (PBSC)

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • Kuala Lumpur Sports Medicine Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have signed informed consent form
  • Patients with only unilateral isolated or multiple knee articular cartilage lesions demonstrated MRI scanning, with up to one previous operation on that knee
  • Patients who are either male or female aged between 18 to 50 years old, corresponding to availability of normative International Knee Documentation Committee (IKDC) data.
  • Female patients of childbearing age must have negative pregnancy tests and are advised to take contraceptive precautions throughout the study.

Exclusion Criteria:

  • Patients with bilateral knee lesions
  • Patients with the presence of ligamentous injury which would require reconstruction, varus or valgus deformity greater than 10 degrees, previous open total menisectomy requiring osteotomy, and cases that require complex surgery prior to cartilage regeneration
  • Patients with significant cognitive impairment, non-ambulatory status or lower extremities amputation other than toes, serious illness or medication affecting operative risk or wound healing (e.g. steroid intake, anticoagulation), and poorly controlled diabetes mellitus with a baseline HbA1c more than 8
  • Patients with significant peripheral vascular disease as indicated by absent dorsalis pedis or posterior tibial pulses.
  • Patients who cannot read English will be excluded from the study as they will be unable to complete the study questionnaires in an objective manner
  • Female patients who are pregnant
  • Patients with any contradictions to MRI scanning
  • Patients with body mass index (BMI) of over 35

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PBSC and Hyaluronic Acid
Peripheral blood stem cells and hyaluronic acid injections
Biological: Peripheral blood stem cells and hyaluronic acid injections
Peripheral blood stem cells and hyaluronic acid injections
Other Names:
  • PBSC and HA
ACTIVE_COMPARATOR: Hyaluronic Acid
Drug: Hyaluronic Acid
Hyaluronic acid injections
Other Names:
  • HA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in tissue histology after subchondral drilling surgery using serial MRI scanning and cartilage biopsies
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved long term functional outcome of subchondral drilling surgery in the knee joint
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuala Lumpur Sports Medicine Centre

Collaborators

Ministry of Science, Technology and Innovation (MOSTI) Malaysia

Investigators

  • Principal Investigator: Khay-Yong Saw, Dr., Kuala Lumpur Sports Medicine Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2012

Study Registration Dates

First Submitted

February 24, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (ESTIMATE)

February 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 12, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLSMC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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